Sorrento Therapeutics Starts Large Efficacy Trial For Intranasal COVID-19 Antibody In UK

The U.K.'s Medicines and Healthcare products Regulatory Agency (MHRA) signed off Sorrento Therapeutics Inc's SRNE Phase 2 trial evaluating COVI-DROPS in newly diagnosed COVID-19 infected patients.
The application was submitted as a rolling application, and the MHRA cleared the study in less than a month from Sorrento's first submission to the MHRA.
The application was supported by the safety data from a healthy subject study completed in the U.S., which showed a safety profile comparable to placebo with doses up to 60 mg.
No serious adverse effects or dose-limiting toxicities were reported, and all adverse effects were mild in severity.
The maximum tolerated dose was not reached.
The efficacy trial is a large double-blind clinical trial enrolling 350 outpatients with COVID-19 who are asymptomatic or have mild symptoms.
The trial will complement the Phase 2 trial currently being started in the U.S. and a separate trial starting in Mexico.
COVI-DROPS is administered as an intranasal instillation in each nares and utilizes the same neutralizing antibody drug substance as COVI-AMG, the intravenous formulation.
The antibody is active against the original SARS-CoV-2 virus and the most prevalent viral variants of concern.
The results of this Phase 2 trial in the U.K. will be combined with the results of the U.S. and Mexico Phase 2 trials.
Price Action: SRNE shares are up 6.99% at $9.49 in the premarket session on the last check Monday.